Anavex Life Sciences Corp (AVXL)

[Investor2014]

Apologies for barging in with an attempted answer.

I think it may be simple:
1) with all the data understood (as well as can be), Anavex will determine inclusion/exclusion criteria so as to optimise the chances of a pass
2) The pass criteria, endpoints, will be agreed upfront with the FDA and noted in the trial protocol
3) Once the final trial readout is presented, the FDA will decided if they agree that the pre-specified endpoints are met.

If 3 is true, then pass!